NCT00829621

Brief Summary

People who have been scheduled for surgery using Bone Morphogenic Protein (called BMP-2) and an incisional vacuum assisted closure device (called IVAC) will be asked to join this study. The purpose of this study is to see if using the IVAC device removes BMP-2 from the wound. BMP-2 is a protein used by the body to increase bone healing, decrease the need for additional surgery, and reduce infection rates. The IVAC is a device that involves a foam dressing secured with an adhesive drape to make an airtight seal over a surgical incision. Tubing runs from the foam dressing to a device that uses gentle suction to drain fluid out (like a vacuum). The IVAC stays on for 48-72 hours depending on amount of drainage. The IVAC by itself helps reduce wound swelling and complications (such as infection).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3 months until next milestone

Results Posted

Study results publicly available

February 21, 2014

Completed
Last Updated

November 7, 2016

Status Verified

October 1, 2016

Enrollment Period

3.4 years

First QC Date

January 26, 2009

Results QC Date

January 1, 2014

Last Update Submit

October 2, 2016

Conditions

Fractures, Closed

Keywords

BMP-2Incisional Vacuum Assisted Closure (IVAC)

Outcome Measures

Primary Outcomes (1)

  • Presence of BMP-2 in Effluent Collected in IVAC Canister

    Presence of BMP-2 in effluent collected in IVAC canister

    12-hours, 24-hours, 36-hours, and 48-hours after IVAC application

Study Arms (2)

75 mmHg suction

ACTIVE COMPARATOR

IVAC suction 75 mmHg

Other: 75 mmHg suction

125 mmHg suction

EXPERIMENTAL

IVAC suction 125 mmHg

Other: 125 mmHg

Interventions

75 mmHg suctionOTHER

Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.

75 mmHg suction
125 mmHgOTHER

Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.

125 mmHg suction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is 18 years or older
  • Subject has tibia fracture requiring treatment with BMP-2
  • Subject to have an Incisional Vacuum Closure (IVAC) Device, placed on the skin directly over the BMP-2 implantation site
  • Subject/guardian able to provide informed consent

You may not qualify if:

  • Subject is less than 18 years old
  • Subject has a wound at fracture/surgical site that cannot be closed
  • Subject/guardian unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Fractures, Closed

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Results Point of Contact

Title
Brett Crist, MD
Organization
University of Missouri, Department of Orthopaedics
cristb@health.missouri.edu
573-882-6562

Study Officials

  • Brett D. Crist, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Co-Director of Trauma Services, Co-Director Trauma Fellowship, Department of Orthopaedic Surgery

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 27, 2009

Study Start

December 1, 2008

Primary Completion

May 1, 2012

Study Completion

December 1, 2013

Last Updated

November 7, 2016

Results First Posted

February 21, 2014

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)